510(k) K101296 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 30, 2010 |
| Received | May 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101296
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2018 | Zimmer Biomet, Inc. Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38
The Segmental System is used for solving complex salvage cases to address patients with severe bone loss as Terminated |
LZO | None listed |
| Feb 27, 2015 | Zimmer, Inc. Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented. Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.